Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

Encephalitis, Tick-borne Clinical Trial

Official title:

Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161824
• Other study ID #: 208
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: October 2001
• Est. completion date: January 2002

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3800
• Est. completion date: January 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

Male and female volunteers were eligible for participation in this study if they:

• Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old

• Were clinically healthy

• Had a negative pregnancy test at the first medical examination, if female and capable of bearing children

• Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children

• Provided written informed consent

• For volunteers under 18 years of age - written informed consent of the parents / guardian was available

• Agreed to keep a volunteer diary

Exclusion Criteria:

• History of any previous TBE vaccination

• History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)

• History of allergic reactions, in particular to one of the components of the vaccine

• Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)

• Received antipyretics within 4 hours prior to the first TBE vaccination

• Suffer from a disease that cannot be effectively treated or stabilized

• Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions

• Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system

• Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)

• Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)

• Had donated blood or plasma within one month of the study start

• Had received banked blood or immunoglobulins within one month of study entry

• Known to be HIV positive (a special HIV test was not required for the purpose of the study)

• Suffering from a febrile illness at study entry

• History of vaccination against yellow fever and / or Japanese B encephalitis

• Participating simultaneously in another clinical trial

• If female: pregnant or breast feeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Locations

Country	Name	City	State
Poland	Zespol Opieki Zdrowotnej w Debicy	Debica
Poland	Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A	Kielce
Poland	"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego	Krakow
Poland	Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"	Krakow
Poland	Szpital Jana Pawla II Oddzial Neuroinfekcji	Krakow
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny	Lubartow
Poland	PANTAMED sp. z o.o.	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland,